MNH · Class II · 21 CFR 888.3070

FDA Product Code MNH: Orthosis, Spondylolisthesis Spinal Fixation

Leading manufacturers include Acromed Corp., Depuyacromed and Medtronic Sofamor Danek, Inc..

309
Total
309
Cleared
127d
Avg days
1995
Since
309 devices
25–48 of 309
Cleared Sep 11, 2006
SFX SNAP-FIT CROSS CONNECTOR
K062196
Depuy Spine, Inc.
Orthopedic · 41d
Cleared Sep 05, 2006
PILOT POSTERIOR LUMBAR PLATING SYSTEM
K061364
Life Spine
Orthopedic · 112d
Cleared Sep 01, 2006
MODIFICATION TO NUVASIVE SPHERX II SYSTEM
K062317
Nuvasive, Inc.
Orthopedic · 23d
Cleared Jul 25, 2006
EBI 5.5 HELICAL FLANGE SPINAL SYSTEM
K061441
Ebi, L.P.
Orthopedic · 62d
Cleared Jul 25, 2006
CD HORIZON SPINAL SYSTEM
K061915
Medtronic Sofamor Danek
Orthopedic · 19d
Cleared Jul 18, 2006
NUVASIVE SPHERX II SYSTEM
K061778
Nuvasive, Inc.
Orthopedic · 22d
Cleared Jul 07, 2006
ZODIAC ADJUSTABLE BRIDGES, MODELS 11-20XX,11-25XX,11-30XX,11-35XX
K061321
Alphatec Spine, Inc.
Orthopedic · 57d
Cleared Apr 12, 2006
NUVASIVE SPHERX SYSTEM
K060225
Nuvasive, Inc.
Orthopedic · 72d
Cleared Jul 27, 2005
XIA 4.5 SPINAL SYSTEM
K050461
Stryker Spine
Orthopedic · 154d
Cleared Mar 02, 2005
STRYKER SPINE TRIO PS
K043180
Stryker Spine
Orthopedic · 105d
Cleared Dec 28, 2004
MODIFICATION TO: CD HORIZON SPINAL SYSTEM
K043343
Medtronic Sofamor Danek
Orthopedic · 22d
Cleared May 20, 2004
PROTEX STABILIZATION SYSTEM
K040442
Globus Medical, Inc.
Orthopedic · 90d
Cleared Apr 21, 2004
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K034056
Medtronic Sofamor Danek
Orthopedic · 113d
Cleared Apr 12, 2004
NUVASIVE SPINAL SYSTEM
K033546
Nuvasive, Inc.
Orthopedic · 152d
Cleared Feb 12, 2004
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K040072
Medtronic Sofamor Danek, Inc.
Orthopedic · 29d
Cleared Dec 15, 2003
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K033322
Medtronic Sofamor Danek
Orthopedic · 61d
Cleared Jun 27, 2003
EBI P148 SPINAL FIXATION SYSTEM
K031423
Ebi, L.P.
Orthopedic · 52d
Cleared Jun 26, 2003
BLACKSTONE SPINAL FIXATION SYSTEM LATERAL OFFSET (SYSTEM MODIFICATION)
K030581
Blackstone Medical, Inc.
Orthopedic · 122d
Cleared Feb 26, 2003
MODIFICATION TO MOSS MIAMI SPINAL SYSTEM POLYAXIAL SCREWS
K030383
Depuyacromed
Orthopedic · 21d
Cleared Jan 28, 2003
MONARCH SPINE SYSTEM
K024348
Depuyacromed
Orthopedic · 29d
Cleared Nov 13, 2002
MODIFICATION TO MONARCH SPINE SYSTEM
K023438
Depuyacromed
Orthopedic · 29d
Cleared Oct 18, 2002
MODIFICATION TO EBI OMEGA21 SPINAL FIXATION SYSTEM
K023204
Ebi, L.P.
Orthopedic · 23d
Cleared Jul 22, 2002
COLORADO 2 SPINAL SYSTEM
K020247
Medtronic Sofamor Danek, Inc.
Orthopedic · 179d
Cleared Jul 11, 2002
MONARCH SPINE SYSTEM
K021335
Depuyacromed
Orthopedic · 76d